FDA 510(k) K203626, SureStrip Vitrification Straw, SureLock Vitrification Straw, by Allwin Medical Devices, Inc.

FDA 510(k) K203626, SureStrip Vitrification Straw, SureLock Vitrification Straw, by Allwin Medical Devices, Inc.

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Device Classification Name: Labware, Assisted Reproduction
510(k) Number: K203626
Device Name: SureStrip Vitrification Straw, SureLock Vitrification Straw
Applicant: Allwin Medical Devices, Inc.
Regulation Number: 884.616
Classification Product Code: MQK
Date Received: 2020-12-11
Decision Date: 2021-06-04
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
510k Review Panel: Obstetrics/Gynecology

Total number of pages: 1,546
Fully redacted pages: 1,052
Content pages: 494

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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